Regulating prescription drugs for patient safety: does Bill C-17 go far enough?
Health Law and Policy, Health Canada, Food and Drug Directorate
Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962.1 However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control.2 Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs Act, allowing the distribution of drug samples only under “prescribed conditions” and prohibiting the sale of any drug listed in Schedule H of the act, including thalidomide.3 The legislation stopped short of granting legal authority to the directorate to unilaterally recall drugs, even though officials recognized that “the cooperation of the manufacturer to recall a drug from the market could not be solely relied on.
Matthew Herder et al, “Regulating prescription drugs for patient safety: does Bill C-17 go far enough?” (2014) 186:8 CMAJ E287–E292.